| || • Responsible for developing, implementing and managing the Site process validation
• Revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs
• Responsibility for all microbial processes (Up- & Downstream until bulk drug substance filling) – own and 3rd party products
• Lead the process validation team operatively and functionally
• Establish, write, maintain Validation Master Plan for process validation & author complex validation protocols
• Maintain overview of state of validation at site, establish project prioritization across site & ensure conduct of site validation activities
• Proactively interact/consult with QA, Global MS&T and others on how to implement and align validation policies and standards
• Develop the strategy for continued process verification (CPV) and annual monitoring batches
• Ensure CPV plans are in place to monitor and trend critical process parameter, quality attributes etc.
• Actively participate respectively lead interdisciplinary and global work groups on process validation topics and related
• Maintain all activities in an inspection ready status and provide the necessary support in any internal or external inspection/audit
| || • Education: University degree (MSc. or PhD) in Chemistry, Pharmacy, Biotechnology, Chemical Engineering, Pharmaceutical Technology or equivalent scientific degree
• Languages: German and English fluent
• Experience: At least 4 years of professional experience in manufacturing, technical development, or quality, minimum of 2 years of experience in executing process validation, having led and managed validation projects. Thorough understanding of manufacturing processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Expert in reviewing and writing technical reports.
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 52.048,50 euros.
Contact: Cornelia Walch, Staffing Manager